BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 7219883 · Received January 25, 2018

    Report

    Report Number
    2939274-2018-50404
    Event Type
    Injury
    Date Received
    January 25, 2018
    Date of Event
    November 11, 2015
    Report Date
    January 4, 2018
    Manufacturer
    OBERDORF : SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR UNKNOWN MATRIXRIB FIXATION PLATES/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. IMPLANT DATE, EXPLANT DATE: UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4)

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE GROEN. F. R. J., DELAWI. D., KRUYT. M. C., ONER. F. C. (2016) EXTENSION TYPE FRACTURE OF THE ANKYLOTIC THORACIC SPINE WITH GROSS DISPLACEMENT CAUSING ESOPHAGEAL RUPTURE. EUR SPINE J. 25:183-187. NETHERLANDS. THE PURPOSE OF THIS STUDY WAS TO DISCUSS THE RELEVANCE OF THE TYPE B3 FRACTURE OF THE NEW AOSPINE CLASSIFICATION. THE STUDY FOLLOWS THE TREATMENT OF ONE (B)(6) MAN WHO SUSTAINED A HIGH-VELOCITY REAR IMPACT ACCIDENT WHILE DRIVING. A COMPUTERIZED TOMOGRAPHY (CT) SCAN SHOWED A HYPEREXTENSION TYPE FRACTURE AT THE LEVEL OF TH4¿TH6. THE PATIENTS RIB FRACTURES WERE STABILIZED USING MATRIXRIB FIXATION PLATES (SYNTHES). SEVEN DAYS AFTER THE IMPLANTATION OF THE SYNTHES DEVICE, 10 DAYS FOLLOWING THE INITIAL TRAUMA THE PATIENT DEVELOPED A HIGH FEVER. BLOOD SAMPLES IDENTIFIED COAGULASE NEGATIVE STAPHYLOCOCCUS (CNS). THE ESOPHAGUS WAS RE-EVALUATED (IT WAS FRACTURED DURING THE ACCIDENT) THROUGH CONTRAST FLUOROSCOPY AND GASTROSCOPY, WHICH DID NOT SHOW RECURRENCE OF LEAKAGE. THE SUBCLAVIA LINE WAS CHANGED, MEROPENEM AND VANCOMYCIN WERE ADDED, AND AFTER 3 DAYS ON MCU THE INFECTION PARAMETERS WEAKENED. THIS REPORT IS FOR UNKNOWN MATRIXRIB FIXATION PLATES. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62900 PLATE, FIXATION, BONE HRS OBERDORF : SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention